Balloon catheter with adjustable inner member

ABSTRACT

A balloon catheter (10) with a shaft (14,24) extending in a longitudinal direction and having a proximal end and a distal end and an inflatable balloon positioned along the shaft. The balloon (12) includes at least one portion connected to the shaft and adapted for moving toward the proximal end thereof when the balloon is inflated. Related aspects are disclosed.

This application is a continuation of U.S. application Ser. No.14/758,622, which is a national stage of PCT/US2013/078427, which claimspriority to U.S. Provisional Application No. 61/747,448, all of whichare incorporated by reference.

TECHNICAL FIELD

This disclosure relates generally to balloons for performing medicalprocedures, such as angioplasty and, more particularly, to a ballooncatheter with an adjustable inner member.

BACKGROUND OF THE INVENTION

Balloons are routinely used to resolve or address flow restrictions orperhaps even complete blockages in tubular areas of the body, such asarteries or veins. In many clinical situations, the restrictions arecaused by hard solids, such as calcified plaque, and require the use ofhigh pressures to compact such blockages. Commercially availableballoons employ complex technology to achieve high pressure requirementswithout sacrificing the profile of the balloon. Besides high pressurerequirements, the balloons should also be resistant to puncture, easy totrack and push, and present a low profile, especially when used forangioplasty.

In clinical practice, angioplasty balloons are expanded from a deflated,folded state to an expanded state within a vessel to treat a targetarea, such as a portion of the circumferential inner wall I of a bloodvessel V, as shown in FIGS. 1 and 2 . The inflation is traditionallycompleted using an X-ray contrast agent to provide better visibilityunder X-ray or other form of radiography during the interventionalprocedure, as illustrated in FIGS. 3 and 4 (note contrast media CMhaving a width DX within the wall 28 of balloon 12, which is bombardedwith radiation R). Typically, a 70/30 percent mixture of contrast agentand saline is used to inflate the balloon during an angioplastyprocedure.

The physician performing the angioplasty procedure should be able tolocate the position of the uninflated balloon with accuracy, so that theballoon will be properly positioned once inflated. This isconventionally accomplished by attaching marker bands on the catheterShaft in the region corresponding to the balloon working surface. This“working surface” is the surface along the portion of the balloon thatis used to achieve the desired treatment effect, such as contacting thecalcified plaque (which surface in the case of a balloon having conicalor tapering sections at the proximal and distal ends is typicallyco-extensive with a generally cylindrical barrel section).

Misalignment of the marker bands during placement along the shaftsometimes results in their failure to correspond precisely to the extentof the working surface, as is shown in FIG. 5 (note misalignment amountX between each interior marker band. M carried by shaft S and workingsurface W of balloon 12, which also typically includes a radiopaque tipP at the distal end). Even upon exercising great care to position themarkers properly on the underlying shaft in alignment with anticipatedboundaries of the working surface when the balloon is inflated, thereremains a tendency for mismatch due to several possible factors. Onesuch factor may be the tolerance stack-ups arising as a consequence ofthe affixation of the balloon to the distal end of the catheter shaft.The balloon also has a tendency to grow in the longitudinal directionwhen inflated, especially with large and particularly long balloons.Another factor is the tendency of the portion of the catheter shaftwithin the balloon to bend or flex during inflation. This may lead tomisalignment between radiopaque markers fixed to the shaft and theworking surface.

Whatever the cause, the resulting misalignment may prevent the clinicianfrom accurately identifying the location of the working surface of theballoon during an interventional procedure. This may lead to ageographic misplacement, or “miss,” of the intended contact between thetarget area T and the working surface W of the balloon 12 (see FIG. 2 ).It is especially desirable to avoid such an outcome when the balloon isdesigned to deliver a payload (such as a drug, stent, or both) or aworking element to a specified location within the vasculature, since amiss may prolong the procedure (such as, for example, by requiringredeployment of the balloon 12 or the use of another balloon catheter inthe case of a drug coated balloon).

During inflation and deflation of the balloon, it is desirable to avoidcertain outcomes. On inflation, the application of pressure to theballoon via the contrast agent may cause the balloon to lengthen in adifferential manner and thus take on a curved, banana-like shape. Thiscurvature can lead to misalignment of the working surface of the balloonwith reference points, such as radiopaque markings provided on anunderlying catheter shaft, or the targeted treatment area. This may leadto a geographic misplacement, or “miss,” of the intended contact betweenthe target area and the working surface of the balloon. It is especiallydesirable to avoid such an outcome when the balloon is designed todeliver a payload (such as a drug, stent, or both) or a working elementto a specified location within the vasculature, since a miss may prolongthe procedure (such as, for example, by requiring redeployment of theballoon 12 or the use of another balloon catheter in the case of a drugcoated balloon).

Upon deflation, the balloon may also be subject to a phenomenon known as“pancaking.” In this condition, the balloon 12 folds down upon itself toa flattened state. This situation may cause the balloon to be viewedthrough fluoroscopy as perhaps still being in the inflated condition,since the full width of the balloon may still be perceived. This cangive the clinician the false perception that the balloon remainsinflated, when in fact it is not.

Accordingly, the need is identified for a balloon catheter that helps toavoid the foregoing problems associated with excessive curvature oninflation, pancaking on deflation, and others

SUMMARY OF THE INVENTION

An object of the disclosure is to provide a balloon having an adjustableinner member that may allow the balloon to foreshorten on inflation.

In one aspect, a balloon catheter comprises a shaft extending in alongitudinal direction and having a proximal end and a distal end and aninflatable balloon positioned along the shaft. The balloon having atleast one portion connected to the shaft and adapted for moving towardthe proximal end thereof when the balloon is inflated.

In one embodiment, an actuator connects the shaft to the balloon. Theactuator may comprise a first position closer to the distal end of theshaft corresponding to a deflated state of the balloon and a secondposition closed to the proximal end of the shaft corresponding to theinflated state of the balloon. The actuator may comprise a telescopingmember including a first portion attached to the balloon and a secondportion attached to the shaft. The first and second portion may includea projection and the other portion may include a recess for receivingthe projection.

The actuator may further comprise a spring. The spring is preferablyarranged so as to shorten the shaft when the balloon is inflated. Theactuator may include threads for manually adjusting the relativeposition of the at least one portion of the balloon.

The portion of the balloon connected to the shaft may be a distal endportion of the balloon. A proximal end portion of the balloon may beadapted for moving toward the distal end of the shaft when the balloonis inflated.

In any embodiment, the catheter may include a hub connected to the shaftin a manner that permits relative movement between the hub and the shaftin a longitudinal direction. The hub may be connected to the shaft by aspring. The hub may be connected to the shaft by a threaded engagement.

The shaft may constrict and shortens in a longitudinal direction oninflation of the balloon. The shaft may include at least one compressionspring.

Another aspect is a balloon catheter comprising a shaft that constrictsin a longitudinal direction on inflation of the balloon.

Still another aspect is a medical balloon connected to a telescopingdevice. One end of the balloon may be connected to a shaft and the otherend connected to a first portion of the telescoping device for receivinga second portion of the telescoping device.

A further aspect of the disclosure relates to a catheter shaft includinga telescoping device adapted for being connected to one end of aninflatable balloon. The end may comprise a distal end or a proximal endof the balloon. The device may include a spring, the spring preferablybeing arranged so as to shorten the shaft when the balloon is inflated.The device may include a threaded connection between a first part and asecond part adapted to telescope within the first part.

A hub may be connected to the shaft in a manner that permits relativemovement between the hub and the shaft in a longitudinal direction. Thehub may be connected to the shaft by a spring, the spring preferablybeing arranged so as to shorten the shaft when the balloon is inflated.The hub may be connected to the shaft by a threaded engagement.

The arrangement may include an inflatable balloon carried by the shaft.The arrangement may further include a compression spring for connectinga first portion of the shaft to a second portion of the shaft.

A related aspect pertains to an apparatus for performing a medicalprocedure, comprising: a shaft extending in a longitudinal direction andhaving a proximal end and a distal end, said shaft supporting aninflatable balloon; and a hub connected to the shaft by a spring or athreaded connection.

Still another aspect relates to a balloon catheter, comprising: aninflatable balloon; and a shaft extending in a longitudinal directionand having a proximal end and a distal end, the shaft including a firstportion and a second portion adapted for constricting to move a portionof the balloon toward the proximal end when the balloon is inflated. Thefirst portion may be connected to the second portion by a compressionspring. The first portion may be connected to the second portion by athreaded engagement. The first portion may be adapted to telescopewithin the second portion.

Also disclosed is a method of using a catheter including a shaft towhich a balloon is attached, comprising constricting the shaft oninflation of the balloon. The step of constricting may comprisetelescoping first and second portions of the shaft. The constricting maybe completed automatically or manually.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1 and 2 show the transition of an angioplasty balloon from adeflated, folded state to an expanded state within a vessel.

FIGS. 3 and 4 illustrate the visibility of an angioplasty balloon duringan angioplasty procedure.

FIG. 5 illustrates the misalignment of a balloon within a vessel duringan inflation of the balloon.

FIGS. 6, 7, 8 and 9 illustrate an angioplasty balloon according to anembodiment of the present disclosure.

FIGS. 10, 10 a and 11 illustrate an angioplasty balloon according to aparticular embodiment of the disclosure.

FIGS. 12 and 13 show a way in which the balloon of FIGS. 10, 10 a and 11is used.

FIGS. 14 and 15 show a further embodiment of the disclosure.

FIGS. 16 and 17 show yet another embodiment of the disclosure.

MODES FOR CARRYING OUT THE INVENTION

The description provided below and in regard to the figures applies toall embodiments unless noted otherwise, and features common to eachembodiment are similarly shown and numbered.

Provided is a catheter 10 having a distal portion 11 with a balloon 12mounted on a catheter tube 14. Referring to FIGS. 6, 7, and 8 , theballoon 12 has an intermediate section 16, or “barrel,” and end sections18, 20. In one embodiment, the end sections 18, 20 reduce in diameter tojoin the intermediate section 16 to the catheter tube 14 (and thussections 18, 20 are generally termed cones or cone sections). Theballoon 12 is sealed at balloon ends (proximal end 15 a and distal end15 b) on the cone sections 18, 20 to allow the inflation of the balloon12 via one or more inflation lumens 17 extending within catheter tube 14and communicating with the interior of the balloon 12.

The catheter tube 14 also includes an elongated, tubular shaft 24forming a guidewire lumen 23 that directs the guidewire 26 through thecatheter 10, and along the distal end of which the balloon 12 may belocated. As illustrated in FIG. 8 , this guidewire 26 may extend throughthe proximal end of the catheter 10 and a first port 25 of a connector27 into the lumen 23 to achieve an “over the wire” (OTW) arrangement,but could also be provided in a “rapid exchange” (RX) configuration, inwhich the guidewire 26 exits a lateral opening 14 a closer to the distalend (see FIG. 9 ) or else is fed through the tip distally of the balloon12 (not shown). A second port 29 may also be associated with catheter10, such as by way of connector 27, for introducing a fluid (e.g.,saline, a contrast agent, or both) into the interior compartment of theballoon 12 via the inflation lumen 17.

Balloon 12 may include a single or multi-layered balloon wall 28 formingthe interior for receiving the inflation fluid. The balloon 12 may be anon-compliant balloon having a balloon wall 28 that maintains its sizeand shape in one or more directions when the balloon is inflated. Theballoon 12 in such case also has a pre-determined surface area thatremains constant during and after inflation, also has a pre-determinedlength and pre-determined diameter that each, or together, retrainconstant during and after inflation. However, the balloon 12 could besemi-compliant or compliant instead, depending on the particular use.

According to one aspect of the disclosure, the catheter 10 may beadapted for helping to allow the balloon 12 to foreshorten duringinflation. This may be achieved by attaching a portion of the balloon 12to the shaft 24 (part of which terms the inner member 24 a within theballoon) in a manner that allows this portion of the balloon to movefrom closer to the distal end 15 b to closer to the proximal end 15 awhen the balloon is inflated. In one embodiment, as shown in FIGS. 10and 11 , an actuator 30 includes a first portion 30 a connected to theshaft 24 at a distal end portion thereof, and a second portion 30 badapted for receiving the first portion 30 a, such as in a telescopingmanner. The two portions 30 a, 30 b are wailingly engaged with eachother so as to contain the inflation fluid within the balloon 12.

In use, and with combined reference to FIGS. 10 and 11 together, theballoon 12 is initially in a folded, deflated condition (12′), with thedistal portion corresponding to end 15 b extended in the distaldirection (such as by the at least partial separation of the telescopingportions 30 a, 30 b). On inflation, the balloon 12 expands, and thusdraws or urges the portions 30 a, 30 b to nest together and thuscompact. This relative constriction or shortening of the shaft 24prevents it from bowing under the resulting pressure that would exist ifthe balloon 12 was immovably fixed to the shaft, and thus helps toprevent the undesirable bowed condition and the correspondingmisalignment that may result.

The portions 30 a, 30 b may also be connected together in a manner thatlimits movement in other directions besides the limited longitudinalmovement. This may be achieved by providing one with a projection (suchas a longitudinal rail) and the other with a corresponding recess (suchas a matching longitudinal groove), as indicated by reference numeral 30c in FIG. 10 a . More than one such mating arrangement may be provided.The arrangement may also include stoppers for defining the amount ofrelative movement permitted.

FIGS. 12 and 13 illustrate that the actuator 30 may also be provided atthe proximal end 15 a of the balloon 12. As the skilled person can inferfrom those figures, the actuator is the same as that shown in FIGS. 10,10 a and 11. In FIG. 12 , the balloon 12 is in the uninflated state(12′) and, thus, the portions 30 a, 30 b are expanded. When inflated theportions 30 a, 30 b nest to provide the desired foreshortening of theshaft 24. In this embodiment, the shaft 24 is shown as being a “duallumen” approach, with an inflation lumen 17 and a guidewire lumen 23 (incommunication with an inflation opening O in the shaft 24 inside theballoon 12) separated by a divider.

Turning to FIG. 14 , an actuator 30 in the form of a biasing element, orspring 32 may also be provided for urging one portion 30 a, 30 b or theother in either the proximal direction or the distal direction dependingon the inflation condition. As is clear from FIG. 14 , the biasingelement 32 is arranged so as to shorten the shaft 24 when the balloon 12is inflated. In lieu of the portions 30 a, 30 b, one or more springs 32may also be provided in an independent manner along another part of theshaft 24, as shown in FIG. 15 . In both instances, the spring 32 maycomprise a compression spring that is normally expanded and thencompresses and shortens the shaft 24, either as a result of inflation inan automatic manner, or as a result of a manual adjustment, as discussedbelow. While illustrated together, it should be appreciated that onlyone of these arrangements could be used, or each could be used aplurality of times.

The portions 30 a, 30 b, may also engage each other using means such asa threaded connection 34 (FIG. 15 ), which may allow for manualadjustments to be made to the relative movement. This may be achieved byproviding an inner shaft 24 that may be rotated, such as by grasping atthe proximal end of the catheter 10 at a connector 27 or hub. Thus, byrotating the inner shaft 24 during inflation, it may be manuallyforeshortened. The threaded connection 34 may also be provided betweenthe connector 27 or hub and a proximal portion of the shaft 24, as shownin FIG. 16 , and the same is the case for the spring 32, as shown inFIG. 17 (which in this placement may be a tension or a compressionspring). As is evident to the skilled person from FIG. 17 , the hub 27is preferably connected to a proximal end of the balloon such that byway of the connector, the balloon can be inflated. The connection couldalso be made by way of a rail connecting the two structures, possiblywith the creation of friction (such as by providing pads) to allow forcontrol of the relative movement. Combinations of any of theseapproaches with those shown in FIGS. 12-17 may also be utilized.

While the disclosure presents certain embodiments to illustrate theinventive concepts, numerous modifications, alterations, and changes tothe described embodiments are possible without departing from the sphereand scope of the present invention, as defined in the appended claims.For example, the ranges and numerical values provided in the variousembodiments are subject to variation due to tolerances, due tovariations in environmental factors and material quality, and due tomodifications of the structure and shape of the balloon, and thus can beconsidered to be approximate and the terms “approximately” or“substantially” means that the relevant value can, at minimum, varybecause of such factors. Accordingly, it is intended that the presentdisclosure not be limited to the described embodiments, but that it hasthe full scope defined by the language of the following claims, andequivalents thereof.

The invention claimed is:
 1. A balloon catheter for use in connectionwith a guidewire, comprising: a catheter shaft extending in alongitudinal direction and having a proximal end and a distal end, thecatheter shaft including an inflation lumen and a guidewire lumen forreceiving the guidewire; and an inflatable balloon including a distalend portion positioned along the catheter shaft, the balloon having atleast one portion connected to the proximal or distal end of thecatheter shaft by an actuator and adapted for moving toward the proximalor distal end thereof on inflation of the balloon to expand from adeflated condition while the distal end of the catheter shaft remainsconnected to the balloon; wherein the inflation lumen is capable ofdelivering inflation fluid to inflate the balloon while the cathetershaft is sealed to the inflatable balloon; wherein the actuatorcomprises a first portion attached to the inflatable balloon and asecond portion attached directly to the catheter shaft within theinflatable balloon and movable independent of the first portion; andwherein the first portion of the actuator is connected to a proximalportion of the balloon.
 2. The catheter of claim 1, wherein the actuatorfurther comprises a spring, the spring being arranged so as to compresswhen the inflatable balloon is inflated.
 3. The catheter of claim 1,further including a hub connected to the proximal end of the shaft in amanner that permits relative movement between the hub and the shaft in alongitudinal direction.
 4. The catheter of claim 3, wherein the hub isconnected to the shaft by a spring.
 5. The catheter of claim 3, whereinthe hub is connected to the shaft by a threaded engagement.
 6. Thecatheter of claim 1, wherein the shaft constricts and shortens in alongitudinal direction on inflation of the inflatable balloon.
 7. Thecatheter of claim 1, wherein the shaft includes at least one compressionspring.
 8. The catheter of claim 1, wherein the distal end portion ofthe inflatable balloon is attached via the actuator to an inner tubeforming the guidewire lumen, and a proximal end portion of the balloonis attached to an outer tube at least partially surrounding the innertube.
 9. The catheter of claim 1, wherein the shaft extends continuouslyfrom a proximal end portion of the inflatable balloon through the distalend portion of the inflatable balloon to an open end, said actuatorcomprising a telescoping connector.
 10. A balloon catheter for use witha guidewire, comprising: a catheter shaft having a proximal end, adistal end, a guidewire lumen for receiving the guidewire, and aninflation lumen; an inflatable balloon extending along the cathetershaft from a proximal end portion of the balloon to a distal end portionof the balloon; and a connector having a first portion attached to theinflatable balloon and a second portion for receiving the cathetershaft, the first portion adapted for sliding along the second portion toallow the inflatable balloon distal end portion to move toward theproximal end of the catheter shaft on inflation of the inflatableballoon to expand to an inflated condition from a deflated conditionwhile the distal end of the catheter shaft remains connected to theinflatable balloon and the first and second portions remain sealinglyengaged so as to contain the inflation fluid within the inflatableballoon; wherein the first portion of the connector is attached to theproximal end portion of the inflatable balloon.
 11. The catheter ofclaim 10, wherein a portion of the catheter shaft proximal to theconnector has a first diameter, the first portion of the connector has asecond diameter greater than the first diameter, and the second portionof the connector has a third diameter greater than the second diameter.12. The apparatus of claim 10, wherein the catheter shaft extends into ahub.
 13. The apparatus of claim 10, wherein the connector is located ata proximal end of the inflatable balloon.
 14. A balloon catheter for usein connection with a guidewire, comprising: a catheter shaft extendingin a longitudinal direction and having a proximal end and a distal end,the catheter shaft including an inflation lumen and a guidewire lumenfor receiving the guidewire; and an inflatable balloon including adistal end portion positioned along the catheter shaft, the balloonhaving at least one portion connected to the proximal or distal end ofthe catheter shaft by an actuator external to the catheter shaft andadapted for moving toward the proximal or distal end thereof oninflation of the inflatable balloon to expand from a deflated conditionwhile the distal end of the catheter shaft remains connected to theinflatable balloon; wherein the inflation lumen is capable of deliveringinflation fluid to inflate the balloon while the catheter shaft issealed to the inflatable balloon; wherein the actuator comprises a firstportion attached to the inflatable balloon and a second portion attacheddirectly to the catheter shaft within the inflatable balloon andattached to the first portion so as to be movable independent of thefirst portion; and wherein the first portion of the actuator is attachedto a proximal portion of the inflatable balloon.